Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— VASC-AKI  

Official title:

Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659589
• Other study ID #: PI2021_843_0143
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pauline Caillard, MD
• Phone: 03 22 45 58 66
• Email: caillard.pauline[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute kidney injury (AKI) is a frequent disease in conventional hospital departments and in intensive care units. It's associated with a high risk to develop chronic kidney disease (CKD), even after a single small AKI episode. It's also associated with an important morbi-mortality, particularly cardiovascular (CV). Some studies have already showed a link between AKI and CV risk but pathologic mechanisms implicated are still unknown. In AKI and CKD, numerous substances, called uremic toxins (UT) are accumulating in blood. In CKD, those toxins, and particularly Indoxyl sulfate (IS), are known to have cardiac and vascular deleterious consequences. However, in AKI, whether acute accumulation of UT may trigger CV complications is unknown.

The purpose of this study is that during AKI, a high UT concentration, in particular IS, would be associated with early vascular and cardiac dysfunctions that can be characterized by the persistence of an accelerated pulse wave velocity (PWV). The main objective is to evaluate the correlation between UT concentrations (especially IS) and arterial stiffness (PWV measurement) at three months of an AKI episode in conventional hospital departments and in the intensive care unit of nephrology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years old.

• Patients hospitalized in conventional hospital departments and in intensive care units of nephrology.

• Patients with moderate to severe AKI (KDIGO 2 or 3) without dialysis.

• AKI from functional or organic aetiology

Exclusion Criteria:

• Patients with severe CKD (GFR<45ml/min/1.73 m2) or with kidney transplants.

• Patients with AKI from septic or obstructive aetiology.

• Patients with AKI from toxic aetiology whose toxic would be also responsable of cardia toxicity.

• Patients with sepsis or blood inflammation.

• Patients with severe chronic cardia dysfunction.

• Patients with arrhythmia or complete heart block.

• Patients with peripheral artery occlusive disease.

• Pregnancy.

• Patients on palliative care.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Dysfunction
• Cardiovascular Prognosis
• Sepsis
• Toxemia
• Uremic; Toxemia
• Vascular Dysfunction
• Wounds and Injuries

Intervention

Other:
• blood sample
Blood sample withdrawal will be done and serum creatinine, IS, PCS, FGF-23, Angiopoietin-2, VCAM-1, E-Selectin and Troponin will be measured.

Locations

Country	Name	City	State
France	Amiens hospital	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pulse wave velocity (PWV) measurement from baseline		at 3 months
Secondary	Correlation between Para-cresyl Sulfate (PCS) concentration and PWV		3 months
Secondary	Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV		3 months
Secondary	Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement		3 months
Secondary	Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function		3 months
Secondary	Correlation between IS concentration and arterial pressure measurement		3 months
Secondary	Correlation between IS concentration and cardiac diastolic function		3 months
Secondary	Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement		3 months
Secondary	Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function		3 months